Full Press Release Details
Tau Medical Announces Full Year 2023 Financial Results and Provides Corporate Update
Positive interim safety and feasibility data from pancreatic cancer study in Montreal, with initial signs of potential dose response
ReSTART U.S. multi-center pivotal trial currently underway -
Submitted PMDA application for recurrent Head and Neck cancer in Japan -
Entered into long-term lease for a second facility in the U.S. in Hudson, NH -
Cash, deposits and restricted deposits balance of $84.9 million, with anticipated runway for at least two years -
March 7, 2024 (GLOBE NEWSWIRE) - Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS,
DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT , reported
full year 2023 financial results and provided a corporate update.
was an incredibly productive year, as we launched our ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma,
which is expected to complete recruitment in the second half of 2024, and as we initiated a number of feasibility trials in difficult-to-treat
internal organ tumors with high unmet need," stated Alpha Tau CEO Uzi Sofer. "We saw meaningful inflection points delivered
by the end of 2023, including strong interim safety and feasibility data from our pancreatic cancer trial in Montreal, with initial signs
of dose response, and our PMDA submission in Japan for pre-market approval. In parallel, we continue to advance our commercial planning
activities and to solidify our supply chain, which was recently bolstered by both a valuable land grant in Jerusalem that is expected
to increase our future manufacturing capacity, as well as by the leasing of a second manufacturing site in the United States. In 2024,
we are focused on completing patient recruitment in our U.S. pivotal ReSTART study and our pancreatic cancer pilot study in Canada, and
on beginning to treat patients in studies targeting a number of other internal organs. We are also exploring the addition of new clinical
trials in the U.S., based upon recent positive regulatory feedback. We expect to begin work on the construction of our second U.S. facility,
in Hudson, NH, and on the construction plans for our second facility in Jerusalem. Alpha Tau expects to remain adequately capitalized
to support all of these programs over the coming years."
Corporate Highlights:
results for the full year ended December 31, 2023
expenses for the year ended December 31, 2023 were $26.4 million, compared to $20.9 million in 2022, due to
increased employee headcount, compensation and benefits, including share-based compensation, increased operating costs, and increased
pre-clinical study and clinical trial expenses, particularly in our U.S. ReSTART trial, with a smaller offset through government grants
from the Israel Innovation Authority.
expenses for the year ended December 31, 2023 were $1.9 million, compared to $1.0 million for 2022 due to increased
employee compensation and benefits, including share-based compensation, and the hiring of our chief commercial officer.
expenses for the year ended December 31, 2023 were $7.3 million, compared to $10.3 million for 2022, due to
to decreased professional fees (including D&O insurance), and costs associated with our financing transaction in the first quarter
expenses (income), net, for the year ended December 31, 2023 were $(6.5) million, compared to $1.6 million for 2022, due to revaluation
of warrants and an increase in interest from bank deposits, offset by changes in foreign exchange rates.
the year ended December 31, 2023, the Company had a net loss of $29.2 million, or $0.42 per share, compared to a net loss of $33.8
million, or $0.53 per share, in 2022.
of December 31, 2023, the Company had cash and cash equivalents, restricted cash and deposits in the amount of $84.9 million,
compared to $105.4 million as of December 31, 2022 and $90.1 million as of September 30, 2023. The Company expects that this cash
balance will be sufficient to fund operations for at least two years.
DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors
by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources
and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse
only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
Alpha Tau Medical, Ltd.
in 2016, Alpha Tau is an Israeli medical device company that focuses on research, development, and potential commercialization of the
Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from
Tel Aviv University.
press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.
When used herein, words including "anticipate," "being," "will," "plan," "may," "continue,"
and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to
expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including
any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various
assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha
Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described
or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's
ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited
operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability
to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence
on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies
to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical
studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha
DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha
Tau's ability to comply with the extensive regulations applicable to it; (xiii) costs related to being a public company; (xiv) risks
related to Alpha Tau's status as a foreign private issuer located in Israel, including those related to the ongoing war between
Israel and Hamas and any further escalations of conflict in the Middle East; (xv) changes in applicable laws or regulations; and the
other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the
SEC on March 7, 2024, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and
other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in
this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While
Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any
obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon
as representing Alpha Tau's views as of any date subsequent to the date of this press release.
| December 31, | ||||||||
| 2022 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 5,836 | $ | 12,657 | ||||
| Restricted cash | 850 | - | ||||||
| Short-term deposits | 98,694 | 69,131 | ||||||
| Restricted deposits | - | 3,152 | ||||||
| Prepaid expenses and other receivables | 1,097 | 816 | ||||||
| Total current assets | 106,477 | 85,756 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Long term prepaid expenses | 391 | 471 | ||||||
| Property and equipment, net | 7,471 | 12,798 | ||||||
| Operating lease right-of-use assets | 5,810 | 8,363 | ||||||
| Total long-term assets | 13,672 | 21,632 | ||||||
| Total assets | $ | 120,149 | $ | 107,388 |
in thousands (except share and per share data)
| December 31, | ||||||||
| 2022 | 2023 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,423 | $ | 2,566 | ||||
| Other payables and accrued expenses | 2,246 | 3,474 | ||||||
| Current maturities of operating lease liabilities | 669 | 1,062 | ||||||
| Total current liabilities | 4,338 | 7,102 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term loan | - | 5,610 | ||||||
| Warrants liability | 5,630 | 3,597 | ||||||
| Operating lease liabilities | 4,524 | 6,604 | ||||||
| Total long-term liabilities | 10,154 | 15,811 | ||||||
| Total liabilities | 14,492 | 22,913 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares of no-par value per share - Authorized: 362,116,800 shares as of December 31, 2022 and 2023; Issued and outstanding: 69,105,000 and 69,670,612 shares as of December 31, 2022 and 2023, respectively | - | - | ||||||
| Additional paid-in capital | 192,259 | 200,234 | ||||||
| Accumulated deficit | (86,602 | ) | (115,759 | ) | ||||
| Total shareholders' equity | 105,657 | 84,475 | ||||||
| Total liabilities and shareholders' equity | $ | 120,149 | $ | 107,388 |
STATEMENTS OF OPERATIONS
in thousands (except share and per share data)
| Year ended December 31, | ||||||||||||
| 2021 | 2022 | 2023 | ||||||||||
| Research and development, net | $ | 11,447 | $ | 20,890 | $ | 26,424 | ||||||
| Marketing expenses | 482 | 974 | 1,924 | |||||||||
| General and administrative | 1,861 | 10,272 | 7,332 | |||||||||
| Total operating loss | 13,790 | 32,136 | 35,680 | |||||||||
| Financial expenses (income), net | 13,474 | 1,606 | (6,539 | ) | ||||||||
| Loss before taxes on income | 27,264 | 33,742 | 29,141 | |||||||||
| Tax on income | 7 | 20 | 16 | |||||||||
| Net loss | 27,271 | 33,762 | 29,157 | |||||||||
| Net comprehensive loss | $ | 27,271 | $ | 33,762 | $ | 29,157 | ||||||
| Net loss per share, basic and diluted | $ | (0.67 | ) | $ | (0.53 | ) | $ | (0.42 | ) | |||
| Weighted-average shares used in computing net loss per share, basic and diluted | 40,534,697* | 63,534,875 | 69,377,922 |